Helping Your Circulation with EDTA Chelation Therapy*

by Michael B. Schachter, MD, FACAM

Most FAIM members and readers of this FAIM newsletter Innovation are at least somewhat familiar with chelation therapy. Innovation published two of my articles on this subject a few years ago. Nevertheless, because this treatment addresses America's number one killer and is so important. I felt that a review and update was timely now. Many people are still dying needlessly each day because they do not know about this therapy. So, for you, your family and your friends, I offer you this information.

Heart attacks are associated with atherosclerosis, a process that results in the accumulation of fats, calcium and other substances in the arterial wall. As a coronary artery narrows, it may become blocked. This results in a reduction of the blood supply to an area of the heart. Heart tissue is damaged and if the area is large enough, the person may die.

The process of atherosclerosis that is so common 'in Americans can also lead to other diseases. For example, strokes are largely the result of atherosclerosis. A blockage of arteries to the legs can lead to a condition known as intermittent claudication, which is a painful cramping of the legs when walking.

Current Conventional Therapy for Heart and Blood Vessel Disorders

Modern treatment for coronary artery disease has generally emphasized coronary artery bypass surgery, balloon angioplasty and/or medications, although some doctors also discuss diet, exercise and other lifestyle factors. But, a remarkably safe and effective treatment for all forms of atherosclerosis has largely been ignored by the vast majority of conventional physicians. This treatment is called EDTA Chelation Therapy.

What Is EDTA Chelation Therapy?

The word "chelation" (pronounced key lay' shun) is derived from the Greek word "chele" meaning the claw of a lobster or crab. It refers to a chemical compound being able to grab onto a mineral in a firm claw-like way. Chelation therapy is the treatment of choice for removing toxic metals, such as lead from the body. EDTA (Ethylene Diamine Tetra acetic Acid) is a synthetic amino acid that is currently approved by the FDA for removing lead and other toxic minerals from the body.

EDTA chelation therapy was first used around 1950 to treat workers suffering from lead poisoning. Several workers, who also had angina from coronary artery disease, reported unexpected 'improvement of their angina. Intrigued by these findings, several physicians subsequently conducted a number of clinical studies which confirmed the benefits of EDTA chelation therapy for all forms of cardiovascular disease. However, since these studies were not double-blind placebo controlled studies, the federal Food and Drug Administration (FDA) has not yet approved the use of EDTA chelation therapy for cardiovascular disorders.

The lack of approval by the FDA for the use of EDTA chelation therapy for cardiovascular disease does not prevent physicians who believe in its benefits from administering it to their patients. Once a drug is approved for one indication, it may be used for other purposes, as long as there exists some medical evidence that it is beneficial.

Although the mechanisms are not fully understood, EDTA, when dripped into the bloodstream, appears to improve circulation. The EDTA combines with certain metals or minerals, forming a complex, which is eliminated by the body in the urine. Analysis done before and after the therapy often reveals improved circulation after a series of infusions.

How It Is Administered

Each 'intravenous infusion of EDTA lasts approximately Four hours. At least twenty to thirty treatments are usually required for symptomatic patients. One or two treatments are given each week.  Follow-up maintenance treatments are administered at longer intervals when indicated.

Full Therapeutic Program

EDTA chelation therapy is generally administered by physicians in the context of a full therapeutic program involving dietary changes, nutritional supplements, an exercise program and recommendations for stress management. Medication is given when necessary and appropriate. With this approach, physicians using this therapy report good to excellent results in 70 to 80% of their patients who have problems due poor circulation involving the heart, legs and/or brain. Symptoms that may improve include: chest pain due to angina, shortness of breath, pain and cramps in the legs with walking, dizziness, impaired memory and generalized weakness or fatigue.

Treats The Whole Body

In contrast to bypass surgery, which treats only the particular arteries that are bypassed, EDTA chelation therapy treats all of the arteries in the body simultaneously. This leads to improvement in circulation to the heart, the brain, the legs and organs of the body. Recent studies show that with treatment there is a gradual reduction of atherosclerotic plaque.  In large arteries and improved blood flow. However, chelation therapy appears to work mainly by improving the circulation in small vessels and promoting the growth of new blood vessels. Large vessel blockage to the legs or brain or heart may still benefit from bypass surgery or angioplasty. These treatments are not mutually exclusive and patients who undergo bypass surgery often benefit from chelation therapy either prior to or after the bypass surgery.

Cost Of Treatment

The cost for each infusion ranges between $90 and $125 in the Metropolitan area. The cost for a full program of thirty infusions over a three or four month period, including office visits, diagnostic tests and nutritional supplements is approximately four to five thousand dollars. Unfortunately, as of this writing, the cost of the infusions and nutritional supplements are usually not covered by Medicare or other medical insurance because, as mentioned previously, the treatment is not yet approved by the FDA for cardiovascular disorders. 

Controversy and Standards

The use of EDTA chelation therapy for cardiovascular disease remains quite controversial and is generally not subscribed to by most physicians in the United States or by major medical organizations, such as the AMA and the American Heart Association. Their position is that this treatment is “unproven” for the above mentioned conditions. However, a national medical association known as ACAM (American College for Advancement in Medicine) has sponsored educational seminars and conferences for physicians on the use of EDTA chelation therapy for the treatment of cardiovascular disorders since 1974. It has established a protocol for the safe and effective administration of EDTA. Many of its members have been certified in the use of chelation therapy by the American Board of Chelation Therapy (ABCT)

Recent Published Studies Supporting EDTA Chelation Therapy

In contrast to the view held by most conventional physicians that there is no medical literature to support the use of EDTA chelation therapy for cardiovascular disease, a, great number of published positive clinical studies do exist. At least 40 clinical studies have been published and only one study has shown negative results. This negative study, which was published in two papers, was conducted by vascular surgeons in Denmark.  The vascular surgeons, whose pocketbooks were being hurt by chelation therapy, had vehemently attacked it in the media for two years prior to the study. The study appears to be severely flawed and is currently being investigated by a Danish agency concerned with integrity in science.

A recent very important study was published in the Journal of Advancement in Medicine. Fall# 1 993.' It was a meta-analysis concerning the effectiveness of EDTA chelation therapy for cardiovascular disease. What is a meta- analysis you might ask? It is a sophisticated study about other studies on a particular subject. L. Terry Chappell. M.D. and John P. Stahl. Ph.D. identified 40 published studies on the use of EDTA chelation therapy for cardio- vascular disease. Nineteen studies met the criteria for inclusion. These nineteen studies included data on 22,765 patients. A high correlation coefficient of 0.88 indicated a, strong relationship between EDTA chelation therapy and improved cardiovascular function. Eighty-seven per- cent of these patients demonstrated clinical improvement by objective testing.

One example of a positive study, included in the meta- analysis and published in 1988 in Medical Hypothesis  by Dr. Efrain Olzewer and Dr. James P. Carter is entitled "EDTA Chelation Therapy in Chronic Degenerative Disease". An analysis was carried out on the treatment results of 2,870 patients with various degenerative and age associated diseases. Using Qualitative, but nevertheless standardized criteria for improvement, the analysis showed either marked or good improvement in:

1. 93.5% of heart patients with coronary disease
2. 98.6% of patients with arteriosclerotic vascular disease of the legs
3. 54% of cerebrovascular and other degenerative diseases of the brain.

The study was carried out in Sao Paulo, Brazil.

A second study done by the same researchers along with a third clinician, Dr. Fuad Calil Sabbag, was a double, blind placebo controlled study, on a small group of only ten patients with advanced atherosclerotic vascular disease of the legs, a condition which results in pain in the legs when walking. This was essentially a black and white study, in which all patients treated with EDTA improved and those who received the placebo did not. This study was published in a peer review Journal. The National Medical Journal in March 1990.6

A third study conducted by Doctors Rudolph and McDonagh was published in the Journal of Advancement In Medicine. Vol. 4. 199 I.' It involved 30 patients with atherosclerotic blockage of one or both of their carotid arteries, shown by doppler imaging studies. The carotids are the large neck arteries that carry blood to the brain. Blockage of a carotid artery may lead to a stroke. The blockage was measured before and after 30 EDTA chelation therapy infusions given over a ten-month period. Results indicated a significant reduction of blockage in these patients and a marked increase in blood flow to the brain. The overall intra-arterial obstruction decreased more than 20 percent. Patients with more severe stenosis had an even greater reduction.

Cost Effectiveness Of EDTA Chelation Therapy

With the justifiably great concern about the costs of a health care program, one important question is whether or not EDTA chelation therapy for cardiovascular disease would be cost effective. Fortunately, this question has been answered by a study in Denmark, which was published in the Fall 1993 issue of the Journal of Advancement in Medicine (the same issue that had the meta analysis study discussed above). C. Hancke, MD and K. Flytile, MD reported on 470 with cardiovascular disease who were treated with EDTA chelation therapy. A variety of parameters were evaluated, most of them being objective. Eighty to ninety-one percent improved, depending on the measurement used. Of 72 patients referred for coronary bypass surgery, only 7 required this procedure following chelation - OF30 patients with arterial blockage of their legs who were referred for amputation of a leg, only 3 required amputation following chelation. Aside from the incredible savings in mortality and morbidity with EDTA chelation therapy as compared to surgical intervention, the estimated cost savings of insurance money in this study was three million dollars. In the United States, the estimated cost savings if EDTA chelation therapy were done on a large scale would be eight billion dollars per year on the savings from coronary bypass surgery alone.

Status of the FDA Approved Study Of EDTA Chelation Therapy

In 1986, the Food and Drug Administration (FDA) issued an Investigational New Drug (IND) certificate to two research organizations to study EDTA chelation therapy in patients with arterial blockage in the legs (intermittent claudication). This double-blind placebo controlled clinical trial was encouraged and partially funded by ACAM physicians and their patients. It was begun at Walter Reed Army Hospital in Washington. D.C. and plans called for patients to be treated at two other military hospitals.  In order for this study to be completed, 120 patients would need to be treated. Treatment of more than thirty patients was completed at Walter Feed Army Hospital. Unfortunately, the Persian Gulf War and funding problems resulted in cessation of the project, which is currently on hold. The code of which patients actually received EDTA and which received placebo has not yet been broken. Following the war, a pharmaceutical company agreed to fund the entire project, but then reneged after hiring a long time opponent of chelation therapy as their new medical director. The study is set up in such away that significant financial benefits would accrue to a company that funds the project, if the trials are successful, as expected. Consequently, members of ACAM are currently seeking the funding to complete the studies. If the FDA approves EDTA chelation therapy for cardiovascular disease, health insurance coverage for the treatment would be forthcoming.

My Personal Experience With EDTA Chelation Therapy

I personally have been chelating patients with cardiovascular disease since 1976, first in my office in Nyack and since April. 1991 in my new modern facility in Suffern.  I estimate that I've chelated at least 1,200 patients during this time with approximately 25,000 intravenous infusions.

I have been active in the American College for Advancement in Medicine (ACAM) almost since its inception (as the American Academy of Medical Preventics , AAMP in 1973) and served as its President from 1989 through 1991. A diplomat of the American Board of Chelation Therapy (ABCT) I have also served on this Board. I lecture to physicians at ACAM workshops, designed to teach physicians from ail over the world about how to do EDTA chelation therapy.

Members of my family and I have received chelation therapy and have benefited considerably. It is interesting to note that virtually all chelating physicians have either taken the treatment themselves or recommended it for their families.

This treatment is one of the most gratifying procedures in my office because most of the patients improve.

Case History

Here is an example of a typical chelation therapy patient. A 50 year old oriental man (Y. O.) had 3 angioplasties from January through June 199 1. The first remained open 12 weeks, the second 8 weeks and the third IO weeks. A fourth was recommended and if it didn't work, his cardiologist suggested that coronary bypass surgery was the only alternative. When first seen in October 199 1, Mr. 0. could walk only two city blocks without severe chest pains. After twenty-four EDTA infusions along with the entire chelation therapy program. Mr. 0. could walk I- 1 1/2 hours, three times per week with little or no discomfort. At the same time, cardiac medications have been reduced by half.

References

1.  Sloth-Nielsen, J., Guldager, B., Mouritzen, C., et al, "Arteriographic Finding in EDTA Chelation Therapy on Peripheral Arteriosclerosis.", American Journal of Surgery, August 1991.

2.  Guldager, B., Jelsnes, R., Jorgensen, S.J., et al, "EDTA Treatment of Intermittent Claudication - A Double-Blind, Placebo Controlled Study.", Journal of Internal Medicine, 1992.

3.  Cranton, M.D., E.M. & Frackelton, J.P., "Negative Danish Study of EDTA Chelation Biased." Townsend Letter for Doctors, July 1992.

4.  Chappell, M.D., L. Terry & Stahl, Ph.D., John P., "The Correlation Between EDTA Chelation Therapy and Improvement in Cardiovascular Function: A Meta-Analysis", Journal of Advancement in Medicine. Fall 1993.  Olszewer, M.D., Efrain & Carter, M.D., Ph.D., James P., "EDTA Chelation Therapy: A Retrospective Study of 2,870 Patients", Journal of Advancement in Medicine, Spring/Summer 1989.

5.  Olszewer, M.D., E., Carter, M.D., Ph.D., J.P. & Sabbag, F.C., "A Pilot Double-Blind Study of Sodium-Magnesium EDTA In Peripheral Vascular Disease", The National Medical Journal, March, 1990.

6.  Rudolph, D.O., Ph.D., C.J., McDonagh, D.O., A.C.G.P., E.W. & Barber, B.S., A.C.S.M., E.T.T., R.K., "A Nonsurgical Approach to Obstructive Carotid Stenosis Using EDTA Chelation", Journal of Advancement in Medicine, Fall 1991.

7.  Hancke, M.D., C. & Flytlie, M.D., K., "Benefits of EDTA Chelation Therapy in Arteriosclerosis: A Retrospective Study of 470 Patients", Journal of Advancement in Medicine, Fall 1993.

*This article was originally printed in the 1994 issue of Innovation, a periodical published by the Foundation for Advancement of Innovative Medicine (FAIM).

© 2000 Michael B. Schachter, MD